EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

B-ADENOMA

Study hypothesis

The aim of this study is to evaluate the effectiveness of using Endocuff Vision in detecting colonic adenomas (polyps in the bowel which may progress to bowel cancer), making sure the procedure is the same or better than the current procedure in all other aspects.

Intervention

Participants undergo a endoscopy as per usual practice. Participants are randomly allocated to one of the groups using randomisation software, stratifying for age group and gender.

Treatment arm: Participants in this arm have the Endocuff Vision mounted on the endoscope for the one-off flexible sigmoidoscopy.

Control arm: The one-off flexible sigmoidoscopy is completed as normal, without the Endocuff Vision on the scope.

Participants are followed up for 14 days after the test test to ensure there are no adverse events.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Adenoma detection rate (ADR) is measured by histological examination of polyps, recorded 14 days after the procedure

Secondary outcome measures

1. Mean adenomas detected per procedure are measured by histological examination of polyps, at 14 days after the procedure2. Rate of cuff exchange (that is, how often the cuff has to be removed) at the time of the procedure3. Complete withdrawal time in procedures where no polyps are detected, measured using withdrawal times at the time of the procedure4. Overall procedure time is measured at time of procedure5. ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation), recorded at the time of the procedure6. Rate of discovered cancers is measured by histological examination of biopsies/polyps, recorded up to 14 days after the procedure7. Examination extent is measured using anatomical assessment of and distance (in centimetres) of intubation at the time of the procedure8. Patient satisfaction is measured using the modified Gloucester scale of assessment of patient comfort at day of procedure and 24 hours after9. Differences in future colonoscopic workload produced by increased ADR is measured using the change in the number of patients referred for full colonoscopy at day of the procedure 10. Changes in ADR to assess any learning curve effect is measured using primary outcome data for the first and last 20% of cases per individual colonoscopist after recruitment has completed11. ADR of each colonoscopist prior to trial recruitment compared with their individual ADR in patients where EndocuffTM Vision was not used is measured using data from the Bowel Cancer Screening programme collected pre-trial and after the trial has completed recruitment from primary outcome data

Overall trial start date

17/03/2016

Overall trial end date

01/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 55 to 61 years (both male and female)2. Referral for screening flexible sigmoidoscopy3. Ability to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 3222; UK Sample Size: 3222

Participant exclusion criteria

1. Absolute contraindications to flexible sigmoidoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes4. Known colonic strictures5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage)6. Patients with active colitis (ulcerative colitis, Crohn’s colitis, diverticulitis, infective colitis)7. Patients lacking capacity to give informed consent8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure 9. Pregnancy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal by October 2019. International presentation at UEGW and BSG annual meetings. Presentation to BSG Endoscopy Research Committee and BCSP

IPD sharing statement:The datasets generated during and/or analysed during the current study is not expected to be made available due to no specific patient consent being given for this.

Intention to publish date

31/10/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/05/2018: Internal review.
16/01/2018: Internal review.
06/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
11/08/2017: Internal review.